Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
DreamStation ASV Recalled by Philips Respironics, Inc. Due to The polyester-based polyurethane (PE-PUR) foam may degrade into...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips Respironics, Inc. directly.
Affected Products
DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.
Quantity: 15,357,775 (10,307,186 in US, 5,039,748 OUS) in total
Why Was This Recalled?
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
Where Was This Sold?
Global distribution
About Philips Respironics, Inc.
Philips Respironics, Inc. has 85 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report